Dear All,
We are swimming in Broad Agency Announcements aka BAAs! As a refresher, I recently shared a BAA from the CDC and one from BARDA — now we have another one from NIAID! There’s a strong biodefense angle here with lots of scope. Key details of each opportunity are as follows and I highly recommend you check out the BAA itself after reading this newsletter:
- Research Area #001 – Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases. Advancing specific vaccine candidates that utilize technology platforms that ideally elicit a rapid onset of immunity following a single dose, provide a durable response and are readily adaptable to multiple emerging pathogens. Due date: 11 Apr 2023, 3p ET.
- Research Area #002 – Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases. Development of new therapeutics for diseases caused by NIAID Emerging Infectious Diseases/Pathogens including Category A, B and C priority pathogens and certain bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report. Due date: 11 Apr 2023, 3p ET.
- Research Area #003 – Antiviral Program for Pandemics (APP): Development of Antivirals for RNA Viral Families of Pandemic Potential. The Antiviral Program for Pandemics aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential. Due date: 13 Mar 2023, 3p ET.
- Research Area #004 – Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases. NIAID is interested in supporting the development of promising diagnostics technologies in three areas for detection of signatures from biothreat pathogens and toxins, as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness. Due date: 11 Apr 2023, 3p ET.
Note the different deadlines for each Research Area! Please share with anyone you think would be interested in this announcement.
I’m please to see the specific Research Area on diagnostics. For those interested in that area, the Duke-Margolis team held a roundtable entitled “Advancing Bacterial Diagnostic Coverage, Reimbursement, and Utilization” last June and have recently released their meeting summary.
Further, my next guest on Fireside Chats may inspire your diagnostic thinking! I met Tina Joshi of the University of Plymouth because she asked me to be in her short educational film for young people. She then agreed to sit down for a Fireside Chat and we had a lively discussion on a variety of topics. Her work on diagnostics is fascinating and I truly enjoyed hearing her perspective on public health advocacy, particularly during the height of COVID-19. Check it out now!
This ~34 min chat was great fun. Tina’s enthusiasm for diagnostics and AMR awareness is infectious!
This ~55 min movie is an educational movie for families and 9-11 year olds on the basics of AMR. Key themes are tackling AMR, hand hygiene and how to make a difference. Well done to Tina and her team!
All best wishes, –jr
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.
Current funding opportunities (most current list is here)
- FDA have announced five RFPs spanning antifungal animal models, usability of antimicrobial drug labeling, urine PK-PD, and interpretive breakpoints. Applications are due dates of 23 Jan 2023 — see this newsletter for more details.
- CDC have announced a very eclectic BAA that covers topics as diverse as surveillance and novel endpoints! White papers are due 3 Feb 2020 — see this newsletter for more details.
- Current funding rounds from CARB-X are as described in this newsletter!
- The AMR Action Fund is now open to proposals for funding of Phase 2 / Phase 3 antibacterial therapeutics. Per its charter, the fund prioritizes investment in treatments that address a pathogen prioritized by the WHO, the CDC and/or other public health entities that: (i) are novel (e.g., absence of known cross-resistance, novel targets, new chemical classes, or new mechanisms of action); and/or (ii) have significant differentiated clinical utility (e.g., differentiated innovation that provides clinical value versus standard of care to prescribers and patients, such as safety/tolerability, oral formulation, different spectrum of activity); and (iii) reduce patient mortality. It is also expected that such agents would have the potential to strongly address the likely requirements for delinked Pull incentives such as the UK (NHS England) subscription pilot and the PASTEUR Act in the US. Submit queries to contact@amractionfund.com.
- BARDA’s long-running BAA-18-100-SOL-00003 offers support for both antibacterial and antifungal agents. This BAA has offered 4 deadlines/year since 2018 … check the most current amendment for details.
- INCATE (Incubator for Antibacterial Therapies in Europe) is an early-stage funding vehicle supporting innovation vs. drug-resistant bacterial infections. The fund provides advice, community, and non-dilutive funding (€10k in Stage I and up to €250k in Stage II) to support early-stage ventures in creating the evidence and building the team needed to get next-level funding. Details and contacts on their website (https://www.incate.net/).
- It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
- The Global AMR R&D Hub’s dynamic dashboard (link) summarizes the global clinical development pipeline, incentives for AMR R&D, and investors/investments in AMR R&D.
- In addition to the lists provided by the Global AMR R&D Hub, you might also be interested in my most current lists of R&D incentives (link) and priority pathogens (link).
Upcoming meetings of interest to the AMR community (most current list is here):
- 1-2 Feb 2023 (virtual): Antimicrobial Chemotherapy Conference by GARDP and BSAC in collaboration with ReAct Africa and Africa CDC. Go here for details.
- [NEW] 2 Feb 2023 (virtual, 10.00-14.00 ET): “Addressing The Challenges,” part 2 of a 2-part series entitled “Improving the Investigation of New Antibacterial Agents for Use in Children.” Convened by I-ACT (Institute for Advanced Clinical Trials for Children) and chaired by I-ACT’s Chief Medical Officer (Gary Noel), this webinar series features an outstanding faculty from Industry, Academia, and Regulatory (both FDA and EMA). Go here for details and to register.
- 16-17 Mar 2023 (timings suggest hybrid EU-US): 7th AMR Conference, hosted by the BEAM Alliance with many co-sponsors. This has historically been a very good networking event. Go here for details.
- 14 Apr 2023 (Copenhagen, Denmark; 3-6.30p CEST): ECCMID and the Global Leaders Group on AMR will jointly sponsor a symposium entitled “Forging partnerships between science and policy in Antimicrobial Resistance (AMR).” Go here to register.
- 15-18 Apr 2023 (Copenhagen, Denmark): 33rd ECCMID. Go here for details and to register.
- 8-12 May 2023 (Lisbon, Portugal): 41st Annual Meeting of the European Society for Paediatric Infectious Diseases. Go here for details.
- [UPDATED DATES] 7-15 Oct 2023 (residential, Annecy, France): ICARe, the Interdisciplinary Course on Antibiotics and Resistance. Now in its 7th year, this course is a deep-dive into the world of antibiotic development. Intense, rigorous, and HIGHLY recommended. Seats are always limited … apply sooner rather than later! Go here for details.
- 20-23 Oct 2023 (Athens, Greece): 11th TIMM (Trends in Medical Mycology). Go here for details.
